PROJECT SUMIVIARY (See instructions): The Biostatistics Core (BC) provides statistical expertise to support study design and data analysis for basic, translational, clinical, and population research at the COHCCC. Areas of expertise include clinical trials; epidemiology; genetics and functional genomics; pharmacokinetic modeling; assays, bioassays, and diagnostics; and animal toxicology testing; as well general statistical methods for data summary, inference, and prediction. The faculty statisticians of the core collaborate in pilot projects, grant proposals, clinical protocols, and publications. Staff statisticians provide additional support, focusing on statistical computing, including the retrieval of data from a variety of databases. The collaborative activities of BC statisticians cover the entire life cycle of a research project, from study design and proposal writing, through monitoring and interim analysis, to final data analyses, statistical graphics and manuscript writing. In addition to supporting collaborative research, the core provides short-term consulting and case-finding services for investigators. Statisticians work closely with the Clinical Protocol and Data Management Core (CPDMC) to ensure that clinical trials are equipped with appropriate case-report forms, databases, and electronic data capture tools. The BC also works closely with the Bioinformatics Core to provide both routine and specialized analysis of functional genomics data. Retrospective studies are often supported by retrieval of data from the COH Cancer Registry, the HSC Transplant database, or other research and clinical repositories. The core provides expertise and access to statistical software such as SAS, JMP, Splus, R, StatXact/LogXact, East, and Nquery, as well as specialized statistical computing tools for microarrays, RNA sequence, human and experimental genetic studies, pharmacokinetics, and clinical trials. Core statisticians provide the Cancer Center with statistical reviews of clinical research protocols, and service on the Cancer Protocol Review and Monitoring Committee (CPRMC), the Institutional Review Board (IRB), and the Data and Safety Monitoring Committee (DSMC). The staff of the BC includes a large part of the Division of Biostatistics, within the Department of Information Science, and the BC enables their participation in Cancer Center-related pilot projects and proposals, which may later develop into externally funded projects. Between 7/1/10 and 6/30/11, the BC was used by 116 principal investigators, 75 of whom are CC members. The BC staff coauthored 33 peer-reviewed cancer-related publications in 2010, and co-authored another 42 by the third quarter of 2011. '